UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037724 |
|---|---|
| Receipt number | R000040819 |
| Scientific Title | Does the fragrance mask reduce the stress of the child during anesthesia introduction? |
| Date of disclosure of the study information | 2019/08/19 |
| Last modified on | 2021/08/25 15:55:57 |
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Basic information
Public title
Does the fragrance mask reduce the stress of the child during anesthesia introduction?
Acronym
the fragrance mask
Scientific Title
Does the fragrance mask reduce the stress of the child during anesthesia introduction?
Scientific Title:Acronym
the fragrance mask
Region
| Japan |
Condition
Condition
The pediatric patients who receive the planned operation for surgery or plastic surgery or urology under the general anesthesia.
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate whether a scented mask improve mask acceptance before slow induction in pediatric patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mask acceptance
Key secondary outcomes
Stress score which are behavior score & pulse rate of the pediatric patients from the entrance of the operating room to induction of the anesthesia.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
the scented mask
Interventions/Control_2
mask
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 2 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the pediatric patients who receive scheduled operation under general anesthesia through mask.
Key exclusion criteria
ASA ps 3
developmental delay
emergency operation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yukako |
| Middle name | |
| Last name | Abukawa |
Organization
Tokyo Jikei University Hospital
Division name
Anesthesia
Zip code
1058471
Address
3-19-18 Nishi shinbashi Minatoku Tokyo
TEL
0334331111
yukakoabukawasandy@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Abukawa |
Organization
Tokyo Jikei University
Division name
Anesthesia
Zip code
1058471
Address
3-19-18 Nishi shinbashi Minatoku Tokyo
TEL
0334331111
Homepage URL
yukakoabukawasandy@yahoo.co.jp
Sponsor or person
Institute
Tokyo Jikei University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Jikei University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Comittee
Address
3-19-18 Nishi shinnbashi Minatoku Tokyo Japan
Tel
03343331111
yukakoabuakawasandy@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 19 | Day |
Last modified on
| 2021 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040819
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
